droplet insulin syringes 0.5ml, 31 x 6mmRecalls & reported problems
Htl Strefa S A · droplet insulin syringes with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05907996095599), received between Feb 7, 2023 and Feb 7, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Complete Blockage” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Complete Blockage1
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2023Complete Blockage; No Flow; Complete Blockage; No Flow
ON(B)(6)2022 HTL-STREFA REGISTERED A COMPLAINT FROM THE CUSTOMER (HTL-STREFA S.A. REF. NO.: (B)(6)2022). BELOW FULL DESCRIPTION OF THE NOTIFICATION: "PATIENT RECEIVED 3 BOXES OF DROPLET INSULIN SYRINGES 31G X 6MM 0.5ML FROM HUMANA WITH LOT NUMBER: 02107171. PATIENT IS FAIRLY NEW TO THE DROPLET BRAND AND HAS BEEN USING BD SYRINGES FOR ROUGHLY 20 YEARS. THE PATIENT CLAIMS THAT THE NEEDLES "HAVE NO HOLE IN THEM," SO THAT HE CANNOT DRAW INSULIN. HE HAS TRIED DRAWING WATER AS WELL, BUT HE WAS UNABLE TO. HE CLAIMS THAT WHEN HE PULLS THE PLUNGER BACK, THE NEEDLE TIP IS PULLED INTO THE SYRINGE. HE HAS HAD THIS ISSUE WITH 2 NEEDLES IN ONE OF THE BOXES. WE ARE SENDING 4 REPLACEMENT BOXES AS A COURTESY AND ARE EXPECTING SAMPLES." THE COMPLAINT WAS FORWARDED TO THE MANUFACTURER (B)(4). CUSTOMER SAMPLE WAS RETURNED TO HTL-STREFA S.A. ON (B)(6)2022 AND RE-SEND TO THE MANUFACTURER FOR THE FURTHER ANALYSIS. THE RESULTS OF THE RETAINED SAMPLE EVALUATION WAS PROVIDED ON (B)(6)2022 AS COMPLAINT OFFICIAL FINAL RESPONSE LETTER COMP(B)(4). THE ARCHIVAL SAMPLES EVALUATION DID NOT REVEAL ANY NONCONFORMITIES THAT COULD CONTRIBUTE TO ARISING COMPLAINED DEFECTS AND NO ANOMALIES FOUND ON BATCH DOCUMENTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16314799 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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